Method of and apparatus for positioning and maintaining the position of endoscopic instruments

ABSTRACT

The present invention provides an apparatus for, and a method of, accurate positioning of endoscopic instruments. Accurate positioning of the instruments is accomplished through the inclusion of a steering ability within the device. After the endoscopic instrument is properly positioned, the present invention may use rapid exchange technology, soft locks, and mechanical locks to maintain the position of the endoscopic instrument. Rapid exchange technology is used to minimize displacement forces present on the guidewire or catheters. Soft locks and mechanical locks resist movements caused by displacement forces.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.10/991,477, filed Nov. 19, 2004, now U.S. Pat. No. 7,635,363, which is acontinuation of U.S. patent application Ser. No. 10/003,678, filed Dec.6, 2001, now U.S. Pat. No. 6,827,718, which is a continuation-in-partU.S. patent application Ser. No. 09/928,655, filed Aug. 14, 2001, nowU.S. Pat. No. 6,676,659, the entire disclosures of which are allincorporated herein by reference in their entirety.

This application is also related to commonly assigned U.S. Pat. Nos.5,921,971; 6,007,522; 6,096,009; 5,547,469; 5,683,362; and 5,868,698,the entire disclosures of which are all incorporated herein by referencein their entirety.

BACKGROUND

1. Field of the Invention

The present invention relates to apparatus and methods used inpositioning and maintaining the position of devices used in catheterprocedures within the human anatomy. The present invention includessteerable devices, locking mechanisms and rapid exchange technologies tominimize or eliminate movement of endoscopic instruments duringendoscopic procedures.

2. Description of Related Art

Historically, the migration of gallstones into an individual's commonbile duct was corrected by general surgical procedures. A surgeon wouldincise the bile duct and remove the gallstones and normally remove thegallbladder. In recent years, less invasive treatment modalities havereplaced these general surgical procedures and reduced patient trauma,long hospital stays and recovery periods.

For example, U.S. Pat. No. 4,696,668 and U.S. Pat. No. 4,781,677, bothto Wilcox, disclose a treatment modality involving the administration ofa dissolution agent in the bile duct to essentially dissolve anygallstones. More specifically, a catheter contains several lumens forinflating and deflating each of two balloons, venting bile, and infusingand aspirating the dissolution agent. Inflating the balloons occludesthe bile duct at two spaced sites and creates a sealed spaced thatreceives the dissolution agent. As the space is sealed from theremaining biliary tree, the dissolution agent finds access to thegallbladder and any gallstones therein through the cystic duct with theexclusion of bile from the gallbladder fundus. The dissolution agentalso will be confined in high concentration around bile duct gallstones.After the gallstones dissolve, the balloons are deflated, and thecatheter can be withdrawn. In this particular approach, the catheter isdirected into the biliary tree using a standard duodenoscope that passesthrough the alimentary tract. Although this and analogous approacheshave the potential of minimizing patient trauma, such treatments requireextended placement of the duodenoscope in the patient, exhibit lowefficacy and introduce a potential for adverse reactions to thedissolution agents.

In an alternative approach, a surgeon directs a surgical extractor intothe biliary tree through at least an incision in the bile duct. Forexample, in U.S. Pat. No. 3,108,593 to Glassman a surgeon incises boththe bile duct and duodenum. Then the surgeon directs an extractorthrough the bile duct incision, biliary tree, sphincter of Oddi andduodenum to exit through the duodenum incision. This extractor includesa series of longitudinally spaced cages for trapping any gallstones inthe bile duct and removing them through either of the incisions.

U.S. Pat. No. 4,627,837 to Gonzalo discloses a catheter device with apair of inflatable balloons at its distal end. This catheter is ledthrough an incision in the bile duct toward the duodenum. After thedistal balloon passes through the sphincter of Oddi, both balloons areexpanded to anchor the catheter in place. This enables the catheter tobe used for irrigating and flushing through other lumens in order tocapture any gallstone in the second balloon for removal through theincised bile duct.

In accordance with still another modality as for the treatment ofstrictures, a surgeon may insert a catheter device through the bile ductor duodenum for the purpose of dilating or enlarging the sphincter ofOddi. For example, U.S. Pat. No. 4,705,041 to Kim discloses a dilatorthat is directed through an incision in the bile duct and the sphincterof Oddi. An expandable tip dilates the sphincter of Oddi. U.S. Pat. No.5,035,696 to Rydell discloses an electrosurgical instrument that isdirected through the duodenum and to the sphincter of Oddi forperforming a sphincterotomy. This apparatus contains a cutting wire thatis heated to cut the sphincter muscle. U.S. Pat. No. 5,024,617 toKarpiel discloses a similar device that can be directed through aduodenoscope. U.S. Pat. No. 5,152,772 to Sewell, Jr. discloses a devicefor performing a sphincterotomy that is directed through an incision inthe bile duct and includes a knife for cutting the sphincter muscle.

The use of the duodenoscope and sphincterotomy devices, such as shown inthe Rydell and Karpiel patents, enables an internist to diagnose andtreat problems in the biliary tree with less patient invasion thanpreviously possible. For example, modalities as described in thesepatents eliminate the surgery needed for incising the bile duct.Consequently, these modalities can be performed as outpatient or daysurgical procedures. These procedures greatly reduce patient trauma, thelength of a hospital stay and recovery times.

The reduced patient trauma, hospital stays and recovery times hasresulted in a growth in the number of endoscopic procedures performedfor treating abnormal pathologies within the alimentary canal system andbiliary tree (including the biliary, hepatic, and pancreatic ducts). Theendoscope provides access to the general area of a desired duct usingdirect visualization. However, the duct itself must be navigated using acatheter in conjunction with fluoroscopy and guide wires,

Catheters are known for treatment of targeted anatomical regions. Knownmethods and devices for using biliary catheters for accessing thebiliary tree for performing catheter procedures are disclosed in Weaveret al., U.S. Pat. No. 5,397,302 and Karpiel, U.S. Pat. No. 5,320,602,the disclosures of which are herein incorporated by reference. Ingeneral, for treatment of an abnormal pathology within a patient'sbiliary tree, an endoscope is first introduced into the mouth of thepatient. The endoscope includes a proximal end and a distal end, and hasa lumen extending longitudinally between the proximal and distal ends.The endoscope is guided through the patient's alimentary tract or canaluntil an opening at the distal end of the endoscope is proximate thearea to receive treatment. At this point, the endoscope allows othercomponents, such as a catheter, to access the targeted area.

For visualization or treatment within the biliary tree, the distal endof the endoscope is positioned proximate the papilla of Vater leading tothe common bile duct and the pancreatic duct. A catheter is guidedthrough the lumen of the endoscope until a distal tip of the catheteremerges from the opening at the distal end of the endoscope.

The catheter may be used for accessing the biliary tree. The distal endof the catheter is guided through the orifice to the papilla of Vater(located near the sphincter of Oddi) leading to the common bile duct andthe pancreatic duct. A guide wire may be used in conjunction with thecatheter to facilitate accessing a desired location within the biliarytree. The guide wire is inserted in an opening at a proximal end of thecatheter and guided through the catheter until it emerges from thedistal end of the catheter.

If visualization of the common bile duct is desired, the guide wire isguided into the common bile duct. The catheter is advanced over theguide wire until the distal end of the catheter is positioned in thecommon bile duct at the desired location. The catheter is now inposition for delivery of contrast media for fluoroscopic visualizationof anatomical detail within the common bile duct.

Visualization may reveal selected areas within the common bile duct thatrequire treatment. To treat the selected areas, a different catheter istypically required, necessitating a catheter exchange. A catheterexchange typically involves removing the first catheter from theendoscope over the guide wire, and advancing a second catheter over theguide wire to the desired treatment site. Thus, once the guide wire isin place relative to the targeted area, it is highly desirable tomaintain the position of the guide wire during subsequent catheterprocedures, including during a catheter exchange procedure. If the guidewire moves during such a procedure, the guide wire may have to bere-directed through the body ducts to the target site, which is often adifficult, time consuming and tedious task.

In addition to performing a catheter exchange procedure, it may also bedesirable to perform a guide wire exchange procedure. This may bedesirable when, for example, a first guide wire is too large to fitthrough a desired body duct, or otherwise lacks the desiredcharacteristics. Under these circumstances, a physician may leave thecatheter in place, withdraw the first guide wire from the catheter, andinsert a second guide wire through the catheter to the desired site.During this procedure, the catheter guides the guide wire to the desiredsite. Thus, once the catheter is positioned at a target site, it ishighly desirable to maintain the position of the catheter during a guidewire exchange procedure so that the second guide wire may be guideddirectly to the desired site in a minimum amount of time.

For example, if an internist determines that gallstones are present inthe biliary tree, particularly the common bile duct, the internist caninsert a duodenoscope into the duodenum to view the sphincter of Oddi.Then a first catheter can be advanced through the working channel of theduodenoscope with or without a guidewire and directed through thesphincter of Oddi into the biliary tree. Contrast agent injected throughthe catheter enables fluoroscopy or other imaging procedures to confirmthe presence of gallstones within the biliary tree. Next, the internistexchanges the first catheter for a second catheter for performing asphincterotomy such as the types disclosed in the above-identifiedRydell and Karpiel patents. The second catheter is then exchanged for athird catheter such as shown in the Glassman patent or some otherequivalent retrieval catheter for drawings gallstones through theenlarged sphincter of Oddi. Thereafter, the retrieval catheter ismanipulated to release the gallstone into the duodenum. The catheter,any guidewire and the duodenoscope can then be removed to complete theprocedure.

This procedure is significantly less traumatic to the patient than otherprior art procedures because the only incision occurs during thesphincterotomy. However, this procedure, as described above, requiresthree separate catheters and two catheter exchanges. These exchanges arerequired because the first, second and third catheters function solelyto inject contrast agent to perform the sphincterotomy and to dislodgegallstones, respectively. The time required for performing each catheterexchange can increase patient trauma and increase the duration of theprocedure and reduce efficiency. Moreover, each such procedure requiresthe use of two or three separate catheter devices.

Multi-lumen catheters are available which typically reduce the number ofcatheters and catheter exchanges used during a procedure and therebyreduce both the time required and the patient's trauma while increasingefficiency. A common problem today concerns the accurate placement of anendoscopic instrument such as a cutting device. Secondly, once thecutting device, such as a sphincterotome, Ultratome, Rapid Exchange,Fluorotome, Papillotome or similar device is properly positioned, theposition of the device must be maintained during the cutting procedure.An example of a common problem with these devices is that after thedevice is positioned and left unattended “set relaxation” occurs inwhich the bow of a cutting instrument undesirably relaxes or straightensout without operator interaction.

Even with multi-lumen catheters, exchanges may be required. To maintainthe position of a guide wire and/or catheter during an exchange, aphysician typically must grasp the proximal end of the guide wire and/orcatheter with one hand, and perform the corresponding exchange with theother. This is difficult, and often results in the movement of the guidewire and/or catheter.

In general, a need exists for an apparatus and method for accuratepositioning of endoscopic instruments, such as cutting devices, and themaintenance of the position of the device.

SUMMARY

Therefore, this invention provides an apparatus for, and a method of,accurate positioning of endoscopic instruments. Accurate positioning ofthe instruments is accomplished through the inclusion of a steeringability within the device. After the endoscopic instrument is properlypositioned, the present invention uses rapid exchange technology, softlocks, and mechanical locks to maintain the position of the endoscopicinstrument. Rapid exchange technology is used to minimize displacementforces present on the guidewire or catheters. Soft locks and mechanicallocks resist movements caused by displacement forces.

The present invention includes an apparatus for use in a treatmentmodality including an enlargement procedure to be performed within apatient. In this embodiment the apparatus includes a catheter for beingdirected through internal passageways in the patient, and the catheterhas a proximal end and a distal end. A proximal portion is adjacent tothe proximal end and a distal portion is adjacent to the distal end. Thecatheter includes a first and at least a second generally parallellumen, which extend between the proximal and the distal portions. Thepresent invention includes a cutting wire for performing the enlargementprocedure extending through the second lumen for operating at the distalportion in response to manipulations at the proximal end. The cuttingwire has a distal end attached to the catheter at the distal end of thesecond lumen. A portion of the cutting wire is external to the catheteralong a length coextensive with a portion of the distal portion of thecatheter. The catheter also includes a handle for operating the cuttingwire from a point proximal of the catheter. A rotatable couplingattaches the handle to the catheter and allows the handle to rotaterelative to the proximal end of the catheter while engaging and rotatinga proximal end of the cutting wire. The rotation of the handle causesthe distal portion of the catheter to rotate. The present invention alsoincludes a locking mechanism for locking an orientation of a distalportion of the cutting wire.

This embodiment of the present invention may further include a rotationlock which inhibits further rotation of the handle relative to theproximal end of the catheter and a rotation indicator configured toindicate an amount of rotation of the handle relative to the proximalend of the catheter. The rotation indicator may include a visualindicator of the amount of rotation and the visual indicator may includean index marking and a corresponding scale marking providing anindication of the amount of rotation. The rotation indicator may alsoinclude a device providing an audible indication in response to therotation of the handle relative to the proximal end of the catheter. Thelocking mechanism of the present invention may include an insertpositioned between moving parts of the apparatus to resist movementbetween the moving parts, or an insert which a guidewire passes throughthe insert and the insert resists movement of the guidewire. The lockingmechanism may include evenly spaced detents in a handle body whichinteract with one or more pawls located in an active cord insert toresist movement of the active cord insert with respect to the handlebody.

In another embodiment of the present invention, the invention includes amethod of cutting tissue in a body passage including selecting acatheter having a first lumen configured for receiving a wire guide anda second lumen configured for receiving an electrosurgical cutting wire.The catheter is positioned in the passage at a desired position using anendoscope, and the electrosurgical cutting wire is actuated in thesecond lumen. In this embodiment, the invention includes orientating theelectrosurgical cutting wire by rotating a handle relative to a proximalend of the catheter and fixing an orientation of the electrosurgicalcutting wire. The orientation of the electrosurgical cutting wire may befixed by an insert which creates friction between moving parts in thecatheter which resists movement between the moving parts. Theorientation may also be fixed with detents which interact with pawls toresist movement between an active cord insert and a handle.

Another embodiment of the present invention includes a catheter handlecomprising a rotatable coupling configured to allow free rotation of aproximal end of a catheter and a clamping member configured to engage aproximal end of a device extending through a lumen formed in thecatheter, whereby rotation of the handle causes rotation of a proximalend of the device in the lumen and a locking mechanism configured toresist movement in a distal end of the device. In this embodiment, thedevice may include a cutting wire extending from the proximal end of thecatheter to and connecting to a distal end of the catheter. A rotationlock may also be included which is engageable to inhibit a rotation ofthe handle with respect to the proximal end of the catheter.

Another embodiment of the present invention includes a catheterincluding a shaft having a proximal end and a distal end. The catheterincludes a guidewire lumen carried by the shaft extending from alocation proximal the distal end of the shaft to a location proximatethe distal end of the shaft. Also included is a cutting device extendingfrom the proximal end of the catheter to a distal portion of thecatheter and where a distal portion of the cutting device is exterior tothe catheter. In this embodiment, means for accessing the guidewirelumen from a location exterior to the catheter shaft, located distal theproximal end of the shaft, are included. These means include a firstopening through the wall of the catheter shaft into the guidewire lumenlocated proximal the distal end of the shaft and a second openingthrough the wall of the shaft located proximal the first opening. Alsoincluded is a channel which gives access to the guide wire lumenextending longitudinally between the first opening and the secondopening. Additionally, means for locking an orientation of the cuttingdevice are also included. In this embodiment, the guidewire lumen may beformed integral to the shaft. Additionally, the channel may include anopening extending longitudinally between the first opening and thesecond opening in communication with the guidewire lumen. The lockingmeans may include an insert positioned between moving parts used toactuate the cutting device wherein the insert resists movement betweenthe moving parts. The locking means may also include detents located ina handle of the catheter and at least one pawl located on an active cordinsert where the active cord insert moves with respect to the handle andthe detents cooperate with the pawl to resist movement of the activecord insert.

Another embodiment of the present invention includes a method ofpositioning a cutting device including a shaft having a proximal end anda distal end, within a patient's lumen comprising the steps of:providing a guidewire lumen within the catheter, extending from alocation proximal the distal end of the shaft to a location proximatethe distal end of the shaft and providing a port through a sidewall ofthe shaft into the guidewire lumen, the port located distal of theproximal end of the shaft. In this embodiment, a guidewire is movedthrough the port relative to the shaft, and the catheter is advancedover the guidewire. The cutting device is actuated so as to expose adistal portion of the cutting device exterior of the catheter, and theorientation of the cutting device is fixed.

BRIEF DESCRIPTION OF THE DRAWINGS

The various objects, advantages and novel features of this inventionwill be more fully apparent from a reading of the following detaileddescription in conjunction with the accompanying drawings in which likereference numerals refer to like parts, and in which:

FIG. 1 is a plan view of one embodiment of apparatus constructed inaccordance with this invention;

FIG. 2 is a cross-section taken along lines 2-2 in FIG. 1;

FIG. 3 is a cross-section taken along lines 3-3 in FIG. 2;

FIG. 4 is a cross-section taken along lines 4-4 in FIG. 2;

FIG. 5 depicts the apparatus of FIG. 1 positioned through a duodenoscopefor injecting contrast agent into the biliary tree;

FIG. 6 is an enlarged view that depicts the orientation of the apparatusin FIG. 1 for performing a sphincterotomy;

FIG. 7 depicts the apparatus of FIG. 1 positioned through a duodenoscopefor dislodging material within the common bile duct;

FIG. 8 is a plan view of one embodiment of apparatus constructed inaccordance with the present invention with a rotatable handle attachedto a cutting wire;

FIG. 8A is a plan view of a snap in handle connection for the apparatusof FIG. 8;

FIG. 9 is a view of the rotatable handle of the present inventionincluding a rotation lock;

FIG. 10 is a detailed view of the rotation lock of FIG. 9;

FIG. 11 is a sectional view along line 11-11 of FIG. 10;

FIG. 12 shows an alignment between the rotatable handle and thebifurcation connector showing zero rotation of the rotatable handle;

FIGS. 13A-D show alternative embodiments of the rotation lock of thepresent invention;

FIGS. 14A-D show cross-sectional areas of the alternate embodiment ofFIGS. 13A-D;

FIGS. 15A-C show three alternative embodiments of rotation markings forthe present invention;

FIGS. 16A and B illustrate a bowing lock included in the presentinvention;

FIG. 17 shows a handle of a Rapid Exchange Tome including an insert toresist movement;

FIG. 18 shows an Ultratome “D” connector incorporating an insert toresist movement;

FIGS. 19A and B show two embodiments of inserts included in a Tomehandle to prevent movement;

FIG. 20 shows an insert included in a body or handle to preventmovement;

FIG. 21 shows an Ultratome XL handle including detents to preventmovement;

FIG. 22 shows an active cord insert which includes a pawl whichcooperates with the handle of FIG. 21 to prevent movement;

FIG. 23 shows the interaction of the detents of FIG. 21 and pawl of FIG.22 to prevent movement;

FIG. 24 is a perspective view of an illustrative locking device;

FIG. 25 is a partial side view of an illustrative locking devicepositioned on an endoscope having an angled side port;

FIG. 26 is a partial side view detailing the illustrative locking deviceof FIG. 25;

FIG. 27 is a perspective view of another illustrative locking device;

FIG. 28 is a perspective view of yet another illustrative lockingdevice;

FIG. 29 is a partial side view of another illustrative locking devicepositioned on an endoscope having an angled side port;

FIG. 30 is a partial elevational view of a catheter in accordance withthe present invention having a guidewire lumen for facilitating rapidcatheter exchange with a guidewire passing therethrough;

FIG. 30A is a cross-sectional view of the catheter of FIG. 30 takenalong line 30A-30A;

FIG. 30B is a cross-sectional view of the catheter of FIG. 30 takenalong line 30B-30B;

FIG. 30C is a cross-sectional view of the catheter of FIG. 30 takenalong line 30C-30C;

FIG. 30D is a cross-sectional view of an alternative embodiment of thecatheter of FIG. 30 in accordance with the present invention, also takenalong line 30C-30C;

FIG. 30E is a partial elevational view of an alternative embodiment ofthe catheter in accordance with the present invention;

FIG. 30F is a cross-sectional view of the catheter of FIG. 30E takenalong line 30E-30F;

FIG. 31 is a partial elevational view of another embodiment of thecatheter in accordance with the present invention;

FIG. 32 is a partial elevational view of another embodiment of thecatheter in accordance with the present invention;

FIG. 32A is a cross-sectional view of the catheter of FIG. 32 takenalong line 32A-32A;

FIG. 32B is a cross-sectional view of the catheter of FIG. 32 takenalong line 32B-3213;

FIG. 33 is a partial elevational view of another embodiment of thecatheter in accordance with the present invention;

FIG. 33A is a cross-sectional view of the catheter of FIG. 33 takenalong line 33A-33A;

FIG. 33B is a cross-sectional view of the catheter of FIG. 33 takenalong line 33B-33B;

FIG. 34 is a partial elevational view of another embodiment of thecatheter in accordance with the present invention;

FIG. 34A is a cross-sectional view of the catheter of FIG. 34 takenalong line 34A-34A;

FIG. 35 is a different partial elevational view of the catheter of FIG.34 having a guidewire disposed therein;

FIG. 35A is a cross-sectional view of the catheter of FIG. 35 takenalong line 35A-35A showing the guidewire received within the lumen ofFIG. 34;

FIG. 36 shows a cut away diagram of an embodiment of the currentinvention which incorporates the rotating handle, locking mechanism andrapid exchange technology into a single catheter;

FIG. 37 shows a non-directional tear in a thinned-wall catheter;

FIG. 38 shows the thinned wall catheter of FIG. 37 positioned through anendoscope detailing the relationship of the guidewire and the catheterwhen a rapid exchange catheter is used; and

FIG. 38A is a sectional view along line 38A-38A of FIG. 38.

DESCRIPTION OF ILLUSTRATED EMBODIMENTS

FIG. 1 depicts catheter apparatus 100 that has the capability ofinjecting a contrast agent into the biliary tree, accurately positioningand maintaining the position of a cutting wire, of performing asphincterotomy and of dislodging a gallstone into the duodenum.Apparatus 100 includes a catheter 101 which, for purposes of definition,includes proximal portion 102 extending from proximal end 103 and distalend 104 with distal portion 105 extending a short distance proximallyfrom distal end 104. In a typical application, catheter 101 will have aworking length of 200 cm and distal portion 105 will have a length of 6cm to 9 cm. Normally, distal portion 105 will have a diameter that issmaller than the diameter of proximal portion 102 to increase theflexibility of distal portion 105. The reduction in diameter also makesdistal end 104 less traumatic and allows distal portion 105 to reachsmaller passages while allowing the larger proximal portion 102 toprovide necessary hoop strength and rigidity, particularly whereproximal portion 102 is coextensive with the working channel of aduodenoscope. For example, the proximal and distal portions might havediameters corresponding to 7 Fr and 5.5 Fr catheter sizes (i.e., 0.09″and 0.07″, respectively).

As shown particularly in FIG. 2, catheter 101 has three lumens. Firstlumen 201 has a diameter that is greater than either second lumen 202 orthird lumen 203. In one particular embodiment, first lumen 201 has adiameter of 0.040″ in proximal portion 102 that reduces to about 0.037″in distal portion 105 to receive a standard 0.035″ guidewire. Inaddition, first lumen 201 is offset from the center of catheter 101.While FIG. 2 shows lumens of various diameters, the present inventionmay be implemented in a catheter which includes lumens of identicalsize.

The cross section of both second lumen 202 and third lumen 203 are shownsmaller than the cross section of first lumen 201 and are radiallyoffset from the centerline of catheter 101, from each other and fromfirst lumen 201. In one particular embodiment, the cross section ofthird lumen 203 has a diameter of 0.028″ in proximal portion 102 thatreduces to about 0.020″ in distal portion 105, and second lumen 202 hasan internal diameter of 0.028″ in proximal portion 102 that reduces toabout 0.020″ in distal portion 105. As described later, this third lumen203 carries a cutting wire for performing a sphincterotomy and forallowing the infusion of a contrast agent at reasonable rates. Theorientation of the cutting wire can also be positioned as desired asfurther described herein. The angular spacing between second lumen 202and third lumen 203 is about 45 degrees, and the angular spacing betweenfirst lumen 201 and each of lumens 202 and 203 each is about 157.5degrees. In this configuration and with these dimensions, proximalportion 102 readily passes through the working channel of anyduodenoscope.

Referring again to FIGS. 1 and 2, each of lumens 201, 202 and 203includes an entry port in proximal portion 102 and an exit port indistal portion 105. Generally, and as described in more detail later,first lumen 201 has an exit port through distal end 104, while the exitports for lumens 202 and 203 can be sited at different locations indistal portion 105 depending upon a particular application.

In FIG. 1, the entry ports in proximal portion 102 adjacent proximal end103 include an entry port 106 that provides access to first lumen 201and includes an optional Luer lock fitting 107. Proximally positionedentry port 108 provides access to second lumen 202 and includes optionalLuer lock fitting 109. Proximal entry port 110 for third lumen 203 islocated coextensively with a portion of handle 111 attached to proximalend 103. One of ordinary skill in the art would understand that thisspecific configuration is given as an example and not meant to limit theinvention. Various other configurations would be apparent to one ofordinary skill in the art to practice the invention described herein.

Referring to FIG. 3, the distal portion 105 of catheter 101 in thisparticular embodiment carries expansible balloon 112 proximally of theexcursion of cutting wire 113 (FIG. 1) externally of catheter 101.Second lumen 202 emerges at distal exit port 301 through the side ofcatheter 101 with the interior of expansible balloon 112. An extension302 of second lumen 202 beyond distal port 301 is sealed by knownmethods of manufacture. Consequently, fluid forced through entrance port108, as by a syringe (not shown) attached to Luer lock fitting 109,expands balloon 112 into an occluding orientation with an inflateddiameter in the range up to 20 mm.

First lumen 201 extends through catheter 101 and terminates with exitport 303 in distal end 104. Thus first lumen 201 is adapted forreceiving a guidewire through the entry port 106 that will extendthrough catheter 101 and exit via exit port 303 in distal end 104 andallow the catheter to slide over that guidewire.

Referring to FIG. 4, distal end 401 of cutting wire 113 attaches to aclamp 402 formed at the distal end of third lumen 203. Spaced skivedports 403 and 404 allow active portion 405 of the cutting wire 113 toemerge from catheter 101 through skived aperture 403, parallel catheter101 exteriorly thereof, and return into third lumen 203 through port 404and reinforcing sleeve 406. Cutting wire 113 then extends through thirdlumen 203 to handle 111 shown in FIG. 1 where it emerges as proximal endportion 114.

Handle 111, as shown in FIG. 1, includes central member 115 terminatingwith thumb ring 116. Central member 115 extends through and slides withrespect to body section 117 having opposed finger rings 118. Centralmember 115 also attaches to catheter 101 at catheter hub assembly 122and is therefore an extension of catheter 101. Body section 117additionally includes internal connector 119 for clamping proximal end114 of cutting wire 113. Thus, when body section 117 is at its distalposition as shown in FIG. 1, distal portion 105 of catheter 101 is inessentially a straight line as shown in FIG. 1 and FIG. 4 with activeportion 305 of cutting wire 113 being closely adjacent catheter 101.Retracting body section 117 causes cutting wire 113 to bend distal end104 upwardly as shown in FIG. 6 to a position that is essentially atright angles to the main axis of the catheter, as will be shown later.

Internal connector 119 and cutting wire 113 are generally conductivemembers that attach through RF connector 120 to RF heating source 121.The use of such RF heating sources 121 for energizing cutting wire 113thereby to cut the sphincter muscle is well known in the art andrepresents one possible sphincterotomy procedure that can be adapted forthe apparatus of this invention and is not described further. RFconnector 120 is also known as an active cord attachment, and the cordfrom the RF heating source may be referred to as an active cord.

With this description of the apparatus structure, it will now bepossible to understand its use in a particular application. FIG. 5discloses, in a partially broken and schematic view, the positioning ofduodenoscope 501 in duodenum 502 adjacent sphincter of Oddi 503.Catheter 101 such as constructed in FIG. 1 passes through sphincter ofOddi 503 into the common bile duct 504, bypassing pancreatic duct 505.Distal end 104 does not extend to gallbladder 506.

Fluoroscopy allows the appropriate positioning by utilizing a series ofradio-opaque markers 507 at distal portion 105 that may include clamp402 and reinforcing sleeve 406 in FIG. 4. Catheter 101 can be positionedwith or without the presence of guidewire 508 in first lumen 201 shownin FIGS. 5, and 7. For purposes of injecting the contrast agent, anyguidewire 508 can be withdrawn to allow the contrast agent to beinjected through first lumen 201 for purposes of fluoroscopicexamination to confirm the presence of one or more gallstones 509. It isalso possible during the operation to expand balloon 112 to occludecommon bile duct 504 and block any migration of contrast agent intoduodenum 502 or pancreatic duct 505.

FIG. 6 is an enlarged view showing duodenum 502, sphincter of Oddi 503,portions of pancreatic duct 505 and common bile duct 504. In FIG. 6,catheter 101 has been positioned relative to the duodenoscope 501through the opening of sphincter of Oddi 503. Body section 117 of handle111 in FIG. 1 has been drawn proximally to deflect distal portion 105into essentially a right angle configuration such that cutting wire 113abuts a portion of sphincter of Oddi 503. The application of RF heatingto cutting wire 113 then will cut sphincter of Oddi 503 and enlarge theopening therethrough. As will be apparent, the sphincterotomy isperformed with direct visualization of the sphincter of Oddi 503 throughduodenoscope 501.

Moreover, as has been observed by others, catheters having guidewire andcutting wire lumens tend to assume a particular angular orientation whendistal portion 105 emerges from the duodenoscope. This orientation isessentially independent of the angular position of the catheter when itis inserted into duodenoscope 501. The offset nature of lumen 203 asshown in FIG. 2, improves the location of cutting wire 113 as distalportion 105 passes through sphincter of Oddi 503. Specifically, theangularly offset brings cutting wire 113 into better alignment withcommon bile duct 504 and displaces the cutting wire from pancreatic duct505.

FIG. 7 depicts the catheter after the sphincterotomy and after catheter101 is advanced over guidewire 508, if used. FIG. 7 also disclosescatheter 101 after balloon 112 has been moved beyond gallstone 509 inbile duct 504. Balloon 112 is expanded so that upon withdrawal ofcatheter 101 balloon 112 will dislodge gallstones 509 and sweep themthrough sphincter of Oddi 503 into duodenum 502.

One of ordinary skill in the art would appreciate that the presentinvention would include switching the orientation of balloon 112 andcutting wire 113. In other words, FIGS. 1, 3 and 4 illustrate anembodiment in which balloon 112 is located proximally of cutting wire113. In an alternative embodiment of the present invention, the balloonmay be located distally of the cutting wire. One of ordinary skill inthe art would also appreciate that the location of the exit ports forthe various lumens may be sited at different locations in distal portion105 depending upon the particular application. For example, second lumen202 may have an exit port located in distal end 104 of distal portion105. This configuration may be desirable for injecting contrast agentdirectly into the biliary tree while the guidewire remains in place infirst lumen 201.

As one of ordinary skill in the art would appreciate, proper positioningof the endoscopic instrument, such as cutting wire 113, is crucial inthe proper treatment of obstructive disease. As explained above,catheters having guidewire and cutting wire lumens tend to assume aparticular angular orientation when distal portion 105 emerges fromduodenoscope 501. Since this orientation is essentially independent ofthe angular position of the catheter when it is inserted intoduodenoscope 501, a need exists to properly position cutting wire 113.Safe and effective results are only obtained through precise positioningof cutting wire 113 and control or maintenance of the portion of theexposed cutting wire.

Due to inconsistencies in the sphincterotome, anatomy, and endoscopemanipulation, it is difficult to accurately and consistently positionthe sphincterotome for proper cannulation. The steerable sphincterotomeof the present invention allows the physician to control the position ofdistal end 104 of the device independently of the endoscope and adjustfor inconsistencies in the device and the anatomy. According to thepresent invention, handle 111 to which cutting wire 113 is attached isfreely rotatable relative to catheter 101. Rotating handle 111 of thepresent invention induces a twisting of attached cutting wire 113, whichallows orientation of distal end 104 without rotating proximal end 103of attached catheter 101.

FIG. 8 shows handle 111 secured to cutting wire 113 at 801 but rotatablerelative to the catheter hub assembly 122 at 802. This configurationprovides a mechanism to rotate cutting wire 113, thereby transmitting aforce used to rotate device end 104. With handle 111 rotatingindependently of catheter hub assembly 122 at proximal end 103, theforce can be applied directly to distal end 104 without twisting theentire shaft. A rotation lock may be included to maintain theorientation of the tip and a rotation marking may be included toindicate the amount of rotation present. An integrated molded luer portassembly 803 for two and three lumen catheters may be provided to snapinto rotatable handle 111 to facilitate fast and economicalmanufacturing, as shown in FIGS. 8 and 8A.

FIG. 9 shows a rotation lock of the present invention. Rotation lock 901enables the user to maintain the orientation of distal end 104. Onemethod of maintaining the orientation of distal end 104 is to maintainthe position of handle 111 relative to bifurcation connector 902 afterhandle 111 has been rotated. Rotation lock 901 allows the user torelease handle 111 at any time during the procedure, while maintainingthe orientation of handle 111 and preventing further rotation whilerotation lock 901 is engaged. Maintaining the position of handle 111maintains the orientation of distal end 104 in the desired orientation.Maintaining the orientation of the distal end 104 reduces the amount oftime and effort required to cannulate if distal end 104 moved.Preventing undesired movement of distal end 104 may also prevent patientinjury. With respect to rotation of handle 111, one of ordinary skill inthe art would appreciate that body section 117 rotates with handle 111,and handle 111 is used as a shorthand when discussing rotation.

FIG. 10 shows two pair of mating detents 1001 and slots 1002 which maybe used to create rotation lock 901. Detents 1001 and slots 1002 arelocated along the central axis of body section 117 at the intersectionof body section 117 and bifurcation connector 902. In FIG. 10, the twopair of detents 1001 and slots 1002 are located 180° apart relative tothe central axis. This configuration creates a lock position every halfrotation of handle 111. During use of the device, as handle 111 isrotated, detents 1001 become disengaged from slots 1002. As detents 1001become disengaged, they compress slightly. As handle 111 reaches aposition 180° from where rotation began, detents 1001 recover from theircompressed state, and engage with slots 1002 once again. As detents 1001traverse from one position to the next, there is a noticeable amount offriction between the mating components. This friction is great enoughthat handle 111 can be released at any time without fear of losing theorientation position of distal end 104.

Rotation lock 901 also serves a secondary function of keeping distal end104 locked in the home position while catheter 101 is being removed fromthe package, inserted into the endoscope, and manipulated through theendoscope. Without this feature, the initial orientation position ofdistal end 104 would become unpredictable. FIG. 11 shows a detaileddiagram of the interaction between detents 1001 and slots 1002.

Referring to FIG. 12, when detents 1001 and slots 1002 are engaged,bifurcation connector 902 and finger rings 118 all lie in the sameplane. This acts as a rotation marker. When finger rings 118 are rotatedinto the same plane as bifurcation connector 902, the rotation lock isengaged, thus signaling 180° of rotation from the last position. The useof a marker such as this allows the user to more easily keep track ofhow much handle 111 has been rotated. This is helpful if the userdesires to move distal end 104 back to its original position. In effect,the user will know, for example, that handle 111 has been rotated threeclicks from the original position. Therefore, to return handle 111 tothe original position, it must be rotated three clicks in the oppositedirection.

FIGS. 13A-13D show alternative embodiments of rotation lock 901. FIG. 13A shows a pure frictional lock. The connection of bifurcation connector902 to handle 111 could be designed such that rotation lock 901 ispurely a function of frictional interference between the two components.Alternative embodiments could include different types of assembly jointsto create this friction. In the primary embodiment, the assembly of thetwo components is accomplished by mating a post or protrusion of thebifurcation connector to a hole of the same size and shape. Alternativeembodiments could reverse this, so that a post or protrusion is part ofthe main body of handle 111. The friction lock could also be built intothe mating faces of main body and bifurcation connector, which areperpendicular to the major axis. FIG. 14A shows a cross section ofrotation lock 902 along 14A-14A of FIG. 13A.

FIG. 13B shows an oval post lock embodiment of the present invention.The connection of bifurcation connector 902 to handle 111 could also bedesigned incorporating an ovalized post 1301 and hole 1302. In thisembodiment, as handle 111 is rotated relative to bifurcation connector902, ovalized hole 1302 would deform, allowing oval post 1301 to rotate.As handle 111 reached a rotation of 180°, ovalized hole 1302 wouldconform back to its original shape, thus locking handle 111 in place. Asshown in FIGS. 13C and 13D, this basic concept may be expanded toincorporate other shapes rather than oval as shown in FIG. 13B. One ofordinary skill in the art would appreciate that the shape of thegeometry, however, governs the degrees of rotation between lockedpositions. For example, if post 1301 and ovalized hole 1302configuration were made up of mating equilateral triangles (FIG. 13C),there would be 120° of rotation between locked positions. Using a squareconfiguration (FIG. 13D), would give 90° between locked positions. FIG.14B illustrates the cross-sectional area across 14B-14B of FIG. 13B.FIG. 14C illustrates the cross-sectional area of FIG. 13C across14C-14C, and FIG. 14D illustrates the cross-sectional area of FIG. 13Dalong cross-section 14D-14D.

FIGS. 15A-C show alternative embodiments by which a rotation marker 1501may be created and included in the present invention. One of ordinaryskill in the art would understand these embodiments may be expanded. Toaid the user in knowing exactly how much handle 111 has been rotatedfrom its original and/or last position, several forms of visual markerscan be incorporated into the design. One alternative embodiment iscomprised of a set of lines placed radially, around the major axis, atthe area where body section 117 and bifurcation connector 902 meets(FIG. 15A). A single line on the stationary component, bifurcationconnector 902, would match up with a corresponding line on body section117. As handle 111 is rotated relative to bifurcation connector 902, theseries of lines or arrows on body section 117 would rotate past thestationary line on bifurcation 902. Each line would indicate anincremental amount of movement. For example, if there were four, equallyspaced lines on the body, each line that passed the marker on thebifurcation connection would signify 90° of rotation.

This feature could be further enhanced by many methods. A series ofnumbers rather than lines could be used to signify the amount ofrotation (FIG. 15C). Alternating colors could also be used to signifythe amount of rotation. Alternating line patterns could be used as well(FIG. 15B).

Another alternative embodiment may use audible tones such as clicks tomake the user aware of the amount of rotation. One method ofincorporating this feature may be to design the rotation lock featuresso that a click is clearly audible at predetermined points along therotational travel of the body. One of ordinary skill in the art wouldalso appreciate that there are several alternative means by which aconnector can be created and that each of these alternatives is includedin the present invention. One of ordinary skill in the art would alsoappreciate that the connector design of the present invention couldeasily be modified to accommodate three or more lumens.

FIGS. 16A and B show additional embodiments of the present inventionwhich may include handle 111 similar to that previously described, butwith the addition of a bowing lock. A bowing lock would aid the user inthat handle 111 could be released at any time and at any orientation,and distal end 104 would maintain its bowed position. Just as rotationlock 901 provides for a safer and more efficient procedure, the bowinglock would perform similarly. The bowing lock could be incorporated intothe design in many ways. The bowing lock, in its simplest form, wouldconsist of friction lock 1601 created between finger rings 118 and bodysection 117 (FIG. 16A). An alternative to this design would create asimilar friction lock, but would use the surfaces between wiretermination 1602 and body section 117 (FIG. 16B). The friction lockshown in FIG. 16B is enhanced by incorporating several lock ribs 1603.Lock ribs 1603 would be used to hold distal end 104 at a specific,predetermined angle. In effect, locking handle 111 into the firstposition would, for example, deflect the tip 30°. The next positionwould, for example, deflect the tip 60°, This feature would give theuser even more control when positioning distal end 104 within theanatomy. In both cases, as finger rings 118 are actuated along bodysection 117, and distal end 104 is bowed, the friction between themating components would hold the position of handle 111, and thus holdthe position of the bow.

FIGS. 17-20 show various configurations of an alternate embodiment ofthe present invention for maintaining the position of an endoscopicinstrument. In each of these configurations, the actuation of varioushandle assemblies has been modified to include an insert which providesa minimal amount of resistance. The resistance added to each of theseconfigurations resists movement of the device away from a set or desiredposition. Each of the embodiments adds friction to the handles by meansof placing a frictional element which provides interference between themoving parts. The interference provides a light braking force whichresists movement in the distal end of a device without user interventionwhen the device is actuated by means of a handle. Each of theembodiments includes a frictional element composed of rubber, silicone,or other suitable material which provides the desired braking force. Theminimal interference of the frictional element ensures that theinterference does not prevent the continuous smooth movement of thehandle actuators present during normal operation of the handle. In apreferred embodiment of the invention, the frictional elements describedresist undesired movement in the distal end without requiring the userto engage, set or actuate a locking mechanism.

FIG. 17 shows a handle 1701 of a Rapid Exchange Tome. Attached to handle1701 is thumb ring 116. In operation, handle 1701 slides within bodysection 117 (not shown). Typically, a post or internal feature of bodysection 117 (not shown) translates within handle cutout 1702. Insert1703 resides within handle cutout 1702 and preferably protrudesoutwardly from handle 1701. The portion of insert 1703 which protrudesout of handle 1701 preferably makes contact with body section 117 andresists motion of body section 117 with respect to handle 1701. One ofordinary skill would appreciate that both the composition of insert 1703and the distance insert 1703 protrudes out of handle 1701 are factors inthe amount of resistance felt in moving body section 117 with respect tohandle 1701.

FIG. 18 shows a “D” connector 1801 of an Ultratome. The incorporation ofinserts at position 1802 and 1803 are used to resist movement of items,such as surgical instrument passing through the inserts.

FIGS. 19A and B show two different embodiments of a soft brake for aTome Handle. In both configurations, wire 1901, such as a guidewire,passes through a D-connector 1902. D-connector 1902 may be modified asshown to include an insert or stopper. FIG. 19A shows a rubber stopper1903 which spans the height of D-connector 1902. As one of ordinaryskill in the art would appreciate, wire 1901 enters D-connector 1902 atwire entrance 1908. Wire 1901 then passes through first section 1904 ofD-connector 1902. Next, wire 1901 passes through first interface 1905between D-connector 1902 and insert 1903. Wire 1901 then passes throughinsert 1903. Similarly, once wire 1901 exits insert 1903, wire 1901passes through second interface 1906 and a wider section 1907 ofD-connector 1902. The passage of wire 1901 through insert 1903 resistsmovement of wire 1901. FIG. 19B shows a similar configuration of insert1904, except that insert 1904 is included in only a section of thevertical portion of D-connector 1902. One of ordinary skill in the artwould appreciate that wire 1901 must pass through a section of insert1904 to allow insert 1904 to resist movement in wire 1901.

FIG. 20 shows another embodiment of the soft brake of the presentinvention. In this embodiment, wire 2001 passes through bushing 2002held within handle 2003. In this configuration, the circumferentialfriction applied to wire 2001 from bushing 2002 will resist wire 2001movement.

FIGS. 21 through 23 show an alternate embodiment of the presentinvention in which a Tome-Loc handle design allows for the precisepositioning and maintenance of the bow angle of a sphincterotome, orsimilar device, during the cutting procedure. This embodiment may beused to reduce or eliminate set relaxation. The design uses evenlyspaced detents 2101 (FIG. 21) machined, or otherwise formed, in handlebody 111 that capture a raised bump or pawl 2202 (FIG. 22) in the activecord insert 2201 (FIG. 22) and hold pawl 2202 or sprag in place. One ofordinary skill in the art would appreciate that detents 2101 may be alsobe molded into handle body 111. Detents 2101 may also be combined withgraduation marks 2102 on the outside of handle body 111 to visually aidbow positioning. The modulus of elasticity of handle 111 acts as aspring to contain pawl 2202. When the device is actuated, handle body111 flexes out and allows pawl 2202 to move on to the next detent withsome slight resistance or a click. The interaction between detent 2101and pawls 2202 would allow the lock to be automatic without requiringadditional buttons or levers to be articulated by the user and may beimplemented to maintain a predictable feel without introducingdifficulty in the manipulation of the device. FIG. 23 shows aninteraction of detents 2101 with pawl 2202. One of ordinary skill in theart would appreciate that the placement of detents 2101 on handle body111 and pawls 2202 on active cord insert 2201 could be reversed in thatdetents could be placed on active cord insert (not shown) and pawls onhandle body 111 (not shown). One of ordinary skill in the art would alsoappreciate that pawl 2202 need not necessarily be a hemispherical designbut could also be a bar type or any type of configuration which wouldresist movement and locate into holes in handle body 111 to facilitatethe detent feature. The basic design would rely on the same principalspreviously described.

FIG. 24 is a perspective view of an illustrative locking device 2401 foruse with an endoscope having a side instrument port. The illustrativelocking device is generally shown at 2401 and includes a body member2402. At one end, body member 2402 includes one or more hook members2403 for attaching locking device 2401 to a shaft of an endoscope or thelike (see FIG. 25). At the other end, body member 2402 includes asecuring mechanism for securing a guide wire or catheter to to lockingdevice 2401. Hook members 2403 may be provided in pairs, as shown inFIG. 24, or offset from one another, as shown in FIG. 27. In eithercase, hook members 2403 are adapted to clip and secure locking device2401 to the shaft of an endoscope or the like. The securing mechanismpreferably includes one or more openings provided in body member 2402.In the embodiment shown, body member 2402 includes a guide wire opening2404 and catheter opening 2405. Guide wire opening 2404 is preferablyJ-shaped, and preferably includes entry slot 2406 and locking slot 2407.Catheter opening 2405 is boot shaped, and also preferably includes entryslot 2408 and locking slot 2409.

Entry slot 2406 of guide wire opening 2404 is dimensioned to be largerthan the diameter of a guide wire. Locking slot 2407 of guide wireopening 2404 is dimensioned to be somewhat smaller than the diameter ofa guide wire. Accordingly, a guide wire can be secured to body member2402 by inserting a portion of the guide wire through entry slot 2406 ofguide wire opening 2404 and into locking slot 2407. Locking slot 2407frictionally secures the guide wire relative to body member 2402.Likewise, entry slot 2408 of catheter opening 2405 is dimensioned to belarger than the diameter of a catheter. Locking slot 2409 of catheteropening 2405 is dimensioned to be somewhat smaller than the diameter ofa catheter. Accordingly, a catheter can be secured to body member 2402by inserting a portion of the catheter through entry end 2408 ofcatheter opening 2405 and into locking slot 2409. Locking slot 2409frictionally secures the catheter relative to body member 2402.

FIG. 25 is a partial side view of an illustrative locking devicepositioned on an endoscope with an angled side port extending therefrom.The endoscope is generally shown at 2501, and includes main shaft 2502with a lumen extending therethrough. Side port 2503 extends laterallyaway from main shaft 2502 at an angle. Side port 2503 provides access tothe lumen of main shaft 2502. Accordingly, a guide wire and/or cathetermay access the lumen of main shaft 2502 via side port 2503. Side port2502 preferably includes side port opening 2504 which is laterallyspaced from main shaft 2502 due to the angular displacement between mainshaft 2502 and side port 2503. Side port opening 2504 is in fluidcommunication with the lumen of main shaft 2502 via connection tube2505. Connection tube 2505 intersects a side wall of main shaft 2502 atan angle, as shown.

A locking device having body member 2506 is shown clipped onto mainshaft 2502 of endoscope 2501. Body member 2506 includes a number of hookmembers 2507 for attaching the locking device to main shaft 2502. Twohook members are visible in FIG. 25. Hook members 2507 are similar tohook members 2403 described above with respect to FIG. 24. Body member2506 extends away from hook members 2507 and generally parallel to sideport 2503. In FIG. 25, body member 2506 is obscured by main shaft 2502and side port 2503. Body member 2506 extends upward past side portopening 2504, wherein a securing mechanism is provided. Preferably, thesecuring mechanism is a J-shaped guide wire opening 2508. As seen inFIG. 25, although partially obscured by main shaft 2502 and side port2503 of endoscope 2501, the attachment means comprising hook members2507 is connected to the distal end of the body member 2506 and thesecuring means comprising the locking slot of the guidewire opening 2508is connected to the proximal end of body member 2506 such thatattachment means such as hook members 2507 are disposed distal of sideport opening 2504 and securing are positioned proximal of side portopening 2504.

In use, a guide wire is advanced into the body via the endoscope. Duringthe advancement of the guide wire, the proximal end thereof may be movedto first position 2509, which is in the entry slot of guide wire opening2508. Once the guide wire is in a desired position within the body, theguide wire may be moved to second position 2510, which is in the lockingslot of guide wire opening 2508. The locking slot of guide wire opening2508 frictionally secures the guide wire relative to body member 2506.

FIG. 26 is a partial side view detailing the illustrative locking deviceof FIG. 25, with an additional oversized catheter opening shown. Theside port of the endoscope is shown at 2503, and the body member of thelocking device is shown at 2506. Positioned proximate side port opening2504 is guide wire opening 2508 and oversized catheter opening 2601.Like above, the guide wire opening is J-shaped and includes an entryslot and a locking slot. Thus, the guide wire may be moved to firstposition 2509, which is in the entry slot of guide wire opening 2508.Once the guide wire is in a desired position within the body, the guidewire may be moved to second position 2510, which is in the locking slotof guide wire opening 2508. The locking slot of guide wire opening 2508frictionally secures the guide wire relative to body member 2506.

Oversized catheter opening 2601 is sized to restrict lateral movement ofcatheter 2602 but not longitudinal movement of catheter 2602. Providinga guide wire opening that can secure the guide wire relative to bodymember 2506 and oversized catheter opening 2601 for only restrictinglateral movement of catheter 2602 may be particularly useful inperforming a catheter exchange procedure. For example, during a catheterexchange procedure, guide wire opening 2508 may maintain the position ofthe guide wire. The oversized catheter opening 2601 may separate thecatheter from the guide wire, as the catheter is withdrawn. The firstand second catheters should be single-operator exchange type cathetersto provide access to the guide wire during the exchange.

FIG. 27 is a perspective view of another illustrative locking device.The embodiment shown in FIG. 27 is similar to the embodiment shown inFIG. 24, but the hook members are laterally offset rather than aligned.For example, hook member 2701 is laterally offset from hook member 2702by a distance “D”. This configuration is another example of anattachment mechanism for attaching the body member to a catheter shaft.

FIG. 28 is a perspective view of yet another illustrative lockingdevice. The locking device is generally shown at 2801, and includes bodymember 2802 having attachment mechanism 2803 at one end and securingmechanism 2804 at the other. Attachment mechanism 2803 includes firsthook member 2805 and second hook member 2806. First hook member 2805 andsecond hook member 2806 are adapted to extend around a substantialportion of the shaft of an endoscope or the like. Thus, first hookmember 2805 and second hook member 2806 may clip body member 2802 to thedesired shaft.

Securing mechanism 2804 includes i-shaped guide wire opening 2807 andflap-type catheter opening 2808. J-shaped guide wire opening 2807operates similar to that described above. Flap-type catheter opening2808 has flap 2809 formed by cutting catheter opening 2808 from bodymember 2802. Flap 2809 is preferably curved to form channel 2810,wherein end portion 2811 of channel 2810 loops back to near the surfaceof body member 2802. In this configuration, a catheter or guide wire maybe selectively provided in channel 2810, which may bend flap 2809 awayfrom body member 2802. Accordingly, flap 2809 may provide force betweenthe guide wire or catheter and body member 2802 to effectively securethe guide wire or catheter to body member 2802.

FIG. 29 is a partial side view of yet another illustrative lockingdevice 2901. Locking device 2901 is positioned between side port 2902and main shaft 2903 of endoscope 2904. Locking device 2901 includes bodymember 2905 that is attached to main shaft 2903 using strap 2906.Preferably, strap 2906 extends around the entire circumference of mainshaft 2903. Further, body member 2905 may include guide wire opening2907 and one or more catheter openings 2908, as shown.

As previously described, the present invention relates to apparatus andmethods used in positioning and maintaining the position of devices usedin catheter procedures within the human anatomy. The present inventionincludes steerable devices, locking mechanisms and rapid exchangetechnologies to minimize or eliminate movement of endoscopic instrumentsduring endoscopic procedures. Rapid exchange technologies may beincluded in the current invention to minimize movement of the deviceswhen a guidewire is removed or a catheter is removed or exchanged.

FIG. 30 shows a partial elevational view of catheter assembly 3009 inaccordance with the present invention. Catheter assembly 3009 is used incatheter procedures for accessing targeted anatomical regions throughthe alimentary canal. The present invention incorporates features whichallow rapid exchange of catheter by a single operator. The catheter ofthe present invention allows shorter length guidewires to be used,resulting in procedures which require less medical personnel, are lesstime consuming, and less costly. Additionally, the present invention isadaptable to most catheter devices used for catheter procedures withinthe alimentary canal.

Catheter assembly 3009 includes catheter 3000 having guidewire 3010passing through a portion thereof. Catheter 3000 includes shaft 3001having proximal end 103 and distal end 104. Operably connected toproximal end 103 of shaft 3001 is catheter hub assembly 122. Catheterhub assembly 122 couples to ancillary devices allowing access to a lumenwithin shaft 3001. Shaft 3001 is preferably formed in an extrusionprocess. Shaft 3001 may be formed of an extruded polymeric material. Inone embodiment, the preferred polymeric material ispolytetrafluoroethylene, polyether block amide, nylon or a combinationor blend of these. Catheters which are contemplated include, but are notlimited to, cannulas, sphincterotomes, cytology devices, and devices forstone retrieval and stent placement.

Shaft 3001 is a generally tubular shaped member having a generallyuniform outer shape at its proximal end. Shaft 3001 may be sized forslidable passage through the lumen of an endoscope. Shaft 3001 includesdistal taper 3002 which tapers to distal portion 105. Distal portion 105may include high contrast, color coded distal markers 3003, andradiopaque distal tip 3004 for fluoroscopic visualization of distalportion 105 during a catheter procedure.

Shaft 3001 further includes proximal port or opening 3005 locatedproximal of distal end 104. Proximal opening 3005 allows access to shaft3001 for passage of guidewire 3010 through shaft 3001. FIG. 30A is across-sectional view of shaft 3001 taken along line 30A-30A at alocation proximal of proximal opening 3005. Proximal to proximal opening3005, guidewire 3010 is positioned adjacent catheter shaft 3001.

Extending longitudinally between the shaft proximal end 103 and distalend 104 is an ancillary lumen 3006 and a second ancillary lumen 3007.Ancillary lumen 3006 and ancillary lumen 3007 may be injection lumens,allowing for high contrast media flow capability for bubble-freeopacification and for excellent visualization of a desired anatomicalregion. Additionally or alternatively, ancillary lumen 3006 and/orancillary lumen 3007 may be used for other ancillary devices, such as acutting wire lumen or a retrieval balloon lumen.

Referring to FIG. 30B, a cross-sectional view of shaft 3001 taken alongline 30B-30B of FIG. 30 is shown. Guidewire lumen 3008 extends betweenproximal opening 3005 and distal end 104. Guidewire 3010 may enterguidewire lumen 3008 at proximal opening 3005. Guidewire lumen 3008 issized for slidable receipt and passage of guidewire 3010 throughguidewire lumen 3008. Referring to FIG. 30C, guidewire lumen 3008extends through distal taper 3002 and distal portion 105. Guidewirelumen 3008 may also extend from distal end guidewire 104.

Although it is recognized that proximal opening 3005 may be located atany location distal of proximal end 103, proximal opening 3005 ispreferably located less than 25 cm from distal end 104. Guidewire lumen3008 is a tubular member which is carried adjacent shaft 3001 ancillarylumen 3006 and ancillary lumen 3007. Guidewire lumen 3008 may be formedintegral with shaft 3001, or alternatively, guidewire lumen 3008 may bepart of a separate tubular member which is coupled to shaft 3001 asshown in FIG. 30D.

Now referring to FIGS. 30E and 30F, an alternative embodiment of thecatheter depicted in FIG. 30 is illustrated. Catheter shaft 3001 of FIG.30E incorporates a proximal guidewire opening which, in conjunction withthe catheter, forms a circular cross section which allows for easyinsertion of the guidewire. As depicted in FIG. 30F, guidewire lumen3008 can include a larger proximal opening which funnels down to thesize of guidewire lumen 3008 which extends distal to the distal end ofcatheter shaft 3001.

Guidewire lumen 3008 allows rapid exchange of catheter 3000 when analternative catheter is necessary during a procedure. Shorter lengthguidewires may be used since guidewire 3010 does not pass throughproximal end 103 and catheter hub assembly 122, but rather enterscatheter shaft 3001 at proximal opening 3005 located substantiallydistal from proximal end 103. The unique catheter construction inaccordance with the present invention will reduce catheter therapeuticand diagnostic procedure time since catheter device exchanges may beperformed relatively more easily and quickly by a single operator.Additional personnel and time associated with maintaining the placementof a conventional (approximately 400 cm) guidewire within the targetedanatomical region is eliminated, reducing the overall costs of theprocedure.

Referring to FIG. 31, a partial elevational view of a distal portion ofcatheter shaft 3001 is shown. Shaft 3001 may further include weakenedarea 3101. Weakened area 3101 extends longitudinally along guidewirelumen 3008 (not shown) between proximal opening 3005 and distal end 104.

When guidewire 3010 is positioned within guidewire lumen 3008, weakenedarea 3101 allows guidewire 3010 to be removed from guidewire lumen 3008by “peeling away” guidewire 3010 from catheter shaft 3001. Weakened area3101 may include less catheter material than the remaining portion ofcatheter shaft 3001, or may be perforated, cut or slit.

At least two different embodiments of weakened area 3101 are possible.In a first embodiment, weakened area 3101 is formed, and a slit,perforation or cut is introduced along the length of weakened area 3101on the outside of catheter 3002 along the side of catheter 3002 whichcontains guidewire lumen 3008. In this embodiment, when removal ofcatheter 3002 is desired, a “directed tear” is performed in which thetear in guidewire lumen 3008 (and catheter 3002) follow the slit, cut orperforation. In a second embodiment, weakened area 3101 is formed byextruding catheter 3002 in a manner which creates sidewalls of catheter3002 thin enough to be torn without requiring slits, cuts orperforations to be introduced after the catheter is extruded. In thisembodiment, when catheter 3002 is to be removed, a non-directional tearoccurs in the outside wall of guidewire lumen 3008. One of ordinaryskill in the art would appreciate that the thin wall approach wouldreduce manufacturing costs and ensure catheters are single use items.The thin wall configuration may also be configured after extrusion suchas by stretching the catheter, molding, or similar procedures.

Another embodiment of the present invention is shown generally in FIG.32. FIG. 32 is a partial elevational view of catheter 3000, which may bea “convertible” catheter design. In catheter 3000, shaft 3001 includesopening 3005 which is skive port 3201 for access to guidewire lumen3008. Catheter 3000 is a convertible catheter design in that an existingcatheter may be modified to include skive port 3201. As a convertiblecatheter design, skive port 3201 is formed by cutting an opening inshaft 3001 for access to guidewire lumen 3008. It is recognized thatcatheter 3000 may be manufactured to include skive port 3201.

Referring to FIG. 32A, proximal to skive port 3201 catheter shaft 3001includes ancillary lumen 3006 and ancillary lumen 3007 as previouslydescribed herein. Additionally, shaft 3001 includes guidewire lumen 3008extending between proximal end 103 and distal end 104, including betweenskive port 3201 and proximal end 103. Referring to FIG. 32B, guidewire3010 may access guidewire lumen 3008 at skive port 3201 and extendthrough guidewire lumen 3008, emerging from distal end 104.

With this embodiment, conventional guidewire techniques may be used forpositioning and exchanging catheter 3000 within a patient's alimentarycanal system. Further, the convertible catheter design incorporatesfeatures which allow rapid exchange of catheters by a single operator.Skive port 3201 opening 3005 allows catheter 3000 to be used in rapidexchange of catheter 3000 when an alternative catheter is necessaryduring a procedure. By allowing guidewire 3010 to enter guidewire lumen3008 a location distal from proximal end 103, relatively shorterguidewires may be used during catheter procedures within the alimentarycanal system, resulting in a more efficient and less costly procedure.

It is recognized that other means for accessing guidewire lumen 3008 ata location distal from proximal end 103 are contemplated within thescope of the present invention. Referring to FIG. 33, a weakenedlocation or slit 3301 is shown within area A for accessing guidewirelumen 3008. Referring to FIG. 33A, proximal to slit 3301, guidewire 3010may be positioned adjacent catheter shaft 3001. Guidewire 3010 entersguidewire lumen 3008 at slit 3301 for passage of guidewire 3010 throughguidewire lumen 3008. Referring to FIG. 33B, guidewire 3010 is slidablycontained within guidewire lumen 3008 at a location distal of slit 3301.With this embodiment, since guidewire lumen 3008 may extendlongitudinally from proximal end 103 to distal end 104, conventionalguidewire techniques may also be used during the catheter procedure.

Referring to FIG. 34, another embodiment of the catheter of the presentinvention incorporating features which allow rapid exchange of cathetersby a single operator is generally shown. Catheter assembly 3004 includesa “port and channel” configuration. For access to guidewire lumen 3008,shaft 3005 includes a first opening or intermediate port 3401 locatedproximal of distal end 104. A second opening or proximal port 3402 islocated proximal of intermediate port 3401 and proximal of distal end104. Extending between intermediate port 3401 and proximal port 3402 islongitudinal channel 3403.

Guidewire lumen 3008 extends longitudinally between proximal end 103 anddistal end 104. Referring to FIG. 34A, channel 3403 is located withinthe wall of catheter shaft 3405, providing access to guidewire lumen3008 between proximal port 3402 and intermediate port 3401. Preferably,channel 3403 includes a radial opening extending between proximal port3402 and intermediate port 3401. It is also recognized that channel 3403may be a weakened area within the wall of the catheter shaft, aperforated area, or a slit which extends between proximal port 3402 andintermediate port 3401. Channel 3403 may also be included bymanufacturing catheter 3405 with thinner exterior walls.

In one embodiment, intermediate port 3401 is located near distal end104, and proximal port 3402 is located near proximal end 103. Referringto FIG. 35, distal end 104 of guidewire 3010 may be inserted withinintermediate port 3401 (not shown), passing through guidewire lumen3008, and emerging from catheter 3000 distal end 104. Referring also toFIG. 35A, guidewire 3010 may then be snapped through channel 3403 intoguidewire lumen 3008 with the proximal end of guidewire 3010 exitingproximal port 3402. With this “port and channel” design, bothconventional and rapid exchange techniques may be used.

FIG. 36 shows a cut away diagram of an embodiment of the currentinvention which incorporates the rotating handle 111, locking mechanism3601 and rapid exchange technology into catheter 3602. In FIG. 36,cutting wire 113 is attached to handle 111 as described with respect toFIGS. 8 and 8A. As handle 111 is rotated, distal end (not shown) ofcutting wire 113 is also rotated to position a cutting portion (notshown) of cutting wire 113 in a desired orientation. Clicks or otheraudible indications may also be incorporated into catheter 3602 toindicate an amount of rotation accepted by handle 111 to an operator. Arotation lock as described in FIGS. 10-14D may also be incorporated intocatheter 3602. The outside of bifurcation connector and body section 117may also include a rotation marker. Guidewire 3010 may enter guidewirelumen 3008 through a proximal port or opening, as described with respectto FIGS. 30-33B, or through a skive port as described in FIGS. 34-35A.Guidewire 3010 may be removed from catheter 3601 through a slit,perforation, cut, or thinned wall of catheter 3602 as described withrespect to FIGS. 30-31. This procedure may permit the placement of asecond catheter over the proximal end of a guidewire and proximal to thefirst catheter to allow rapid introduction of the second catheter oncethe first catheter is torn away.

FIG. 37 shows a non-directional tear in a thinned-wall catheter 3602.When it is desired to separate catheter 3602 from guidewire 3010, aforce is exerted on guidewire 3010 in a direction away from catheter3602, or on catheter 3602 in a direction away from guidewire 3010 whichcauses catheter 3602 to tear 3701 in a non-directional manner. One ofordinary skill in the art would appreciate from FIG. 37 that catheter3602 above point 3703 where guidewire 3010 contacts catheter 3602 hasnot been perforated, cut or slit as indicated near reference number3702. As additional pressure is exerted on guidewire 3010 or catheter3602, tear 3701 will continue toward distal end 104.

FIG. 38 shows catheter 3602 positioned through endoscope 3801 detailingthe relationship of the guidewire and the catheter when a rapid exchangecatheter is used. When a catheter exchange is required or desired, theposition of guidewire 3010 may be maintained by withdrawing catheter3602 from the patient and tearing catheter 3602 from guidewire 3010.

FIG. 38A is a sectional view along line 38A-38A of FIG. 38. As catheter3801 is torn from guidewire 3010, a portion of the thinned wall ofcatheter 3801 is torn in a non-directional manner 3802. One of ordinaryskill in the art would appreciate that by introducing slits, cuts orperforations into catheter 3801, a directional tear may be assured.

While the present invention is described in terms of a catheter used inaccessing the biliary tree, one of ordinary skill in the art wouldappreciate that the present invention includes the introduction of anendoscopic instrument into any body lumen. In other embodiments, thepresent invention may be used to position and maintain the orientationof an endoscopic instrument within any body lumen. For example, thepresent invention may be incorporated into a catheter for use in, butnot limited to, the pulmonary system, vascular ducts, or urino-genitalprocedures.

1. An apparatus for the accurate positioning of endoscopic instruments,comprising: an elongate catheter shaft having a proximal portion, adistal portion, an outer surface, and a lumen formed therein; a handlecoupled to the proximal portion of the catheter shaft; a cutting wirehaving a first portion attached to the distal portion of the cathetershaft, a second portion disposed along the outer surface of the cathetershaft, and a third portion attached to the handle; wherein the handle iscoupled to the catheter shaft with a rotatable coupling that allows thehandle to rotate independently of the catheter shaft; a rotationindicator that is configured to indicate the amount of rotation of thehandle relative to the catheter shaft; and wherein the rotationindicator includes an audible indicator.
 2. The apparatus of claim 1,further comprising a locking mechanism for locking the position of thefirst portion of the cutting wire.
 3. The apparatus of claim 1, whereinthe rotation indicator includes a visual indicator.
 4. The apparatus ofclaim 1, wherein the distal portion of the catheter shaft has a firstouter diameter and wherein the proximal portion of the catheter shafthas a second outer diameter greater than the first outer diameter. 5.The apparatus of claim 1, wherein the catheter shaft has two or morelumens formed therein.
 6. The apparatus of claim 5, wherein the cathetershaft has three lumens formed therein.
 7. A medical device, comprising:an elongate catheter shaft having a proximal portion, a distal portion,an outer surface, and a lumen formed therein; a handle coupled to theproximal portion of the catheter shaft; a cutting wire having a firstportion attached to the distal portion of the catheter shaft, a secondportion disposed along the outer surface of the catheter shaft, and athird portion extending through the lumen and being attached to thehandle; wherein the handle is coupled to the catheter shaft with arotatable coupling that allows the handle and the cutting wire to rotateindependently of the catheter shaft; and a rotation lock for preventingrotation of the catheter shaft relative to the handle, the rotation lockbeing disposed between the handle and the shaft and allowing for thehandle to be released from the catheter shaft.
 8. The medical device ofclaim 7, further comprising a rotation indicator that is configured toindicate the amount of rotation of the handle relative to the cathetershaft.
 9. The medical device of claim 7, wherein the rotation lockincludes a first pair of detents and the handle includes a second pairof detents configured to mate with the first pair of detents.
 10. Themedical device of claim 7, wherein the rotation lock is a friction lockthat includes a post that frictionally engages the handle.
 11. Themedical device of claim 10, wherein the post includes an oval post. 12.The medical device of claim 10, wherein the post includes a triangularpost.
 13. The medical device of claim 10, wherein the post includes asquare post.
 14. The medical device of claim 7, wherein the handleincludes a brake configured to resist movement of a guidewire within thecatheter shaft.
 15. A medical device, comprising: an elongate cathetershaft having a proximal portion, a distal portion, an outer surface, anda lumen formed therein; a handle coupled to the proximal portion of thecatheter shaft, the handle being rotatable relative to the cathetershaft; a cutting wire having a first portion attached to the distalportion of the catheter shaft, a second portion disposed along the outersurface of the catheter shaft, and a third portion extending through thelumen and being attached to the handle; a rotation lock for preventingrotation of the catheter shaft relative to the handle; and wherein therotation lock is disposed between the handle and the shaft and allowsfor the handle to be released from the catheter shaft.
 16. A medicaldevice, comprising: an elongate catheter shaft having a proximalportion, a distal portion, an outer surface, and a lumen formed therein;a handle coupled to the proximal portion of the catheter shaft, thehandle being rotatable relative to the catheter shaft; a cutting wirehaving a first portion attached to the distal portion of the cathetershaft, a second portion disposed along the outer surface of the cathetershaft, and a third portion extending through the lumen and beingattached to the handle; a rotation lock disposed between the handle andthe catheter shaft for preventing rotation of the catheter shaftrelative to the handle; and wherein the rotation lock is a friction lockthat includes a post that frictionally engages the handle.
 17. A medicaldevice, comprising: an elongate catheter shaft having a proximalportion, a distal portion, an outer surface, and a lumen formed therein;a handle coupled to the proximal portion of the catheter shaft, thehandle being rotatable relative to the catheter shaft; a cutting wirehaving a first portion attached to the distal portion of the cathetershaft, a second portion disposed along the outer surface of the cathetershaft, and a third portion extending through the lumen and beingattached to the handle; a rotation lock for preventing rotation of thecatheter shaft relative to the handle; and a guidewire extending throughthe catheter shaft; wherein the handle includes a brake that isconfigured to resist movement of the guidewire relative to the cathetershaft.